Self Etching Primer SEPR

GUDID D798SEPR0

The Reliance S.E.P.™ is a self etching primer refill cartridge intended to be used for the preparation of an enamel surface of a tooth prior to bonding with a light cure orthodontic adhesive.

RELIANCE ORTHODONTIC PRODUCTS INC

Dental etching solution Dental etching solution

• Primary Device ID: D798SEPR0
• NIH Device Record Key: 6d49348a-fd44-4d94-b49f-b05c4a9f01cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Self Etching Primer
• Version Model Number: SEPR
• Catalog Number: SEPR
• Company DUNS: 113170088
• Company Name: RELIANCE ORTHODONTIC PRODUCTS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *TEMPERATURE LIMITATIONS: Store refill cartridges refrigerated (2-8 Degrees C). Do not freeze.Allow product to reach room temperature prior to use.Avoid exposure to light.
• Special Storage Condition, Specify: Between 0 and 0 *TEMPERATURE LIMITATIONS: Store refill cartridges refrigerated (2-8 Degrees C). Do not freeze.Allow product to reach room temperature prior to use.Avoid exposure to light.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D798SEPR0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071688

FDA Product Code

• KLE: Agent, Tooth Bonding, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-13

On-Brand Devices [Self Etching Primer]

• D798SEPR0: The Reliance S.E.P.™ is a self etching primer refill cartridge intended to be used for the pre
• D798SEPPRO0: The Reliance S.E.P.™ is a self etching primer Kit intended to be used for the preparation of
• D798SEPD0: The Reliance S.E.P.™ is a self etching primer dispenser is intended to be used for the deliver
• D798SEPC0: The Reliance S.E.P.™ is a self etching primer Kit intended to be used for the preparation of